Psychological Intervention for Persons in the Early Initial Prodromal State

Sponsor

University of Cologne (Other)

Overall Status

Unknown status

CT.gov ID

NCT00204087

Collaborator

German Federal Ministry of Education and Research (Other), German Research Network On Schizophrenia (Other), Department of Psychiatry University of Bonn (Other), Heinrich-Heine University, Duesseldorf (Other), Ludwig-Maximilians - University of Munich (Other)

126

Enrollment

Location

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this randomized controlled trial is to develop a cognitive behavioral therapy (CBT) for persons with at risk mental states in the early initial prodromal state and to evaluate CBT in comparison to supportive counselling (SC).It is hypothesized that CBT is more effective than SC on transition to subthreshold psychosis, psychosis and schizophrenia as well as on prodromal symptoms and social adjustment.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Psychosis	Behavioral: Cognitive behavioral therapy (CBT) Behavioral: Supportive Counselling (SC)	Phase 3

Detailed Description

Several studies indicated that self-perceived cognitive thought and perception deficits (basic symptoms), negative symptoms, anxiety, depressive symptoms and social stagnation or social decline are usually present years before the first episode of schizophrenia appears. It is also known that delayed treatment of schizophrenia correlates with a poor prognosis, low compliance and high family burden. As consequence of these findings, for the first time we developed a cognitive behavioral therapy (CBT) for persons at risk for psychosis in the early initial prodromal state. The early initial prodromal state was defined by the presence of self-perseived neuropsychological deficits, which were found to be predictive for transition to psychosis and by the presence of clinical relevant decline of functioning in combination with that of clinical management (CM). Is CBT more effective than CM with regard to the three aims of intervention 1. transition to psychosis, 2. improvement of prodromal symptoms, 3. prevention of social decline/stagnation, ? A randomized controlled trail is used to compare the efficacy of CBT with that of supportive counselling (SC). Patients are randomized to receive either CBT or SC over a 12 months period. CBT comprises of individual and group therapy as well as cognitive remediation and psychoeducation for key persons. SC should provide regular supportive contacts for the patient. No CBT strategies are allowed to be systematically applied in SC.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Psychological Intervention for Persons at Risk of Psychosis in the Early Initial Prodromal State

Study Start Date :

Jan 1, 2001

Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

transition to subthreshold psychosis (and psychosis or schizophrenia) []

Secondary Outcome Measures

improvement of prodromal symptoms (basic symptoms, depression, anxiety) []
social adjustment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 36 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

General criteria

Age between 17 and 36 years
male or female, in- or outpatients
written informed consent, for patients below 18 years also signed by their parents

Special criteria (presented within the last three months prior to the study)
Self-experienced neuropsychological deficits (basic symptoms)

Thought interferences
Compulsory like perseverance of thoughts
Thought pressure
Thought blockages
Disturbances of receptive language, either heard or read
Decreased ability to discriminate between ideas and perception, fantasy and true memories
Unstable ideas of reference (subject-centrism)
Derealisation
Visual perceptual disturbances (blurred vision, transitory blindness, partial seeing, hypersensitivity of light, etc..)
Acoustic perceptual disturbances (hypersensitivity to sounds or noise (hypersensitivity to sounds or noise, acoasms, etc.) AND/OR

Reduction in the Global Assessment of Functioning Score (DSM IV) of at least 30 points (within the past year) and at least one of the following risk factors:

First-degree relative with a lifetime-diagnosis of schizophrenia or
a schizophrenia spectrum disorder
Pre-or perinatal complications

Exclusion Criteria:

Attenuated or transient positive symptomes
Present or past diagnosis of a schizophrenic, schizophreniform, schizoaffective, delusional or bipolar according to DSM IV
Present or past diagnosis a brief psychotic disorder according to DSM IV with a duration of more than one week or within the last 4 weeks regardless of its duration
Diagnosis of delirium, dementia, amnestic or other cognitive disorder, mental retardation psychiatric disorder due to a somatic factor or related to the consumption of psychotropic substances according DSM IV
Alcohol- or drug abuse within the last three months prior to inclusion according to DSM IV
Deases of the central nervous system (inflammatory, traumatic, epilepsy etc.)